This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group, Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight following administration for 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
174
Unnamed facility
Costa Mesa, California, United States
Change in HbA1c from baseline at 12 weeks
Time frame: Day 1 to Week 12
Percentage of subjects who achieve HbA1c <7% at 12 weeks
Time frame: Day 1 to Week 12
Change in body weight from baseline at 12 weeks
Time frame: Day 1 to Week 12
Change in plasma glucose levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
Change in lipid Levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
Change in insulin levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
Change in C-peptide levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
Adverse Events
Time frame: Day 1 to Week 14
Blood Pressure
Time frame: Day 1 to Week 14
Electrocardiogram Parameters
Time frame: Day 1 to Week 14
Hematology
Time frame: Day 1 to Week 14
Blood Chemistry
Time frame: Day 1 to Week 14
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Unnamed facility
Encino, California, United States
Unnamed facility
Huntington Park, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
DeLand, Florida, United States
Unnamed facility
Miami Lakes, Florida, United States
Unnamed facility
Port Orange, Florida, United States
Unnamed facility
Tampa, Florida, United States
...and 20 more locations
Urinalysis
Time frame: Day 1 to Week 14
Pulse
Time frame: Day 1 to Week 14